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NCT Number: NCT07607925

A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL

The goal of this clinical trial is to learn if drug GSK5926371 works to treat a form of B-cell cancer (a type of blood cancer) that has returned or failed to respond to prior therapies in adults. The study will primarily assess the drugs safety and tolerability in participants. Additionally, it seeks to determine the clinical efficacy and pharmacokinetic (PK) properties of GSK5926371.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
  • Has measurable disease,
  • Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;
  • Has documented disease relapse, progression or disease refractory to the most recent line of therapy, per Lugano criteria.:
  • Willing to use adequate contraception (Participant of childbearing potential [POCBP] only).
  • Is capable of giving signed informed consent
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Has adequate organ function.

Exclusion criteria

  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.
  • Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.
  • Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions.
  • Has an active uncontrolled infection.
  • Has received a prior Allogeneic stem cell transplant (allo-SCT) within 12 months prior to the first dose of GSK5926371 or has active graft-versus-host disease requiring systemic immunosuppressive therapy.
  • Has received a prior autologous stem cell transplant within 100 days prior to the first dose of GSK5926371.
  • Has received prior treatment with Chimeric antigen receptor T-cell (CAR-T) therapy within 12 weeks of first GSK5926371 administration.
  • Has received prior treatment with CD19- or CD20-targeting Bispecific antibody (BsAbs) within 8 weeks of the first dose of study intervention.
  • Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.
  • Has significant cardiovascular disease such as uncontrolled arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction <=45% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment.

Treatment and study plan

GSK5926371

Drug

GSK5926371 will be administered at different dose levels.

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: Up to 28 days

  2. Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity

    Time frame: Up to approximately 169 weeks

Secondary outcomes

  1. Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)

    Time frame: Up to approximately 169 weeks

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 169 weeks

    ORR is defined as the percentage of participants in the ORR evaluable set with the best overall response of confirmed partial response (PR) or better per Lugano guidelines as assessed by investigator.

  3. Maximum concentration (Cmax) of GSK5926371

    Time frame: Up to approximately 169 weeks

  4. Time to Cmax (Tmax) of GSK5926371

    Time frame: Up to approximately 169 weeks

  5. Area under the curve (AUC) of GSK5926371

    Time frame: Up to approximately 169 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 27, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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